Literature DB >> 32648772

Clinical application of volumetric absorptive microsampling to the gefapixant development program.

Brad Roadcap1, Azher Hussain1, Dan Dreyer1, Keynu Carter1, Neal Dube1, Yang Xu1, Melanie Anderson1, Erwin Berthier2, Faye Vazvaei1, Kevin Bateman1, Eric Woolf1.   

Abstract

In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC-MS/MS bioanalytical method was developed and validated using VAMS to support this development program. This method was utilized in a drug-drug interaction study to establish a mathematical bridging relationship with data obtained from a validated plasma assay used to support the program. The VAMS bioanalytical method and the predictability of the mathematical relationship is reported and discussed here.

Entities:  

Keywords:  Tasso OnDemand; VAMS; dried blood; gefapixant

Mesh:

Substances:

Year:  2020        PMID: 32648772     DOI: 10.4155/bio-2020-0074

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  8 in total

1.  homeRNA: A Self-Sampling Kit for the Collection of Peripheral Blood and Stabilization of RNA.

Authors:  Amanda J Haack; Fang Yun Lim; Dakota S Kennedy; John H Day; Karen N Adams; Jing J Lee; Erwin Berthier; Ashleigh B Theberge
Journal:  Anal Chem       Date:  2021-09-21       Impact factor: 8.008

2.  Accuracy and tolerability of self-sampling of capillary blood for analysis of inflammation and autoantibodies in rheumatoid arthritis patients-results from a randomized controlled trial.

Authors:  Johannes Knitza; Koray Tascilar; Nicolas Vuillerme; Ekaterina Eimer; Paul Matusewicz; Giulia Corte; Louis Schuster; Timothée Aubourg; Gerlinde Bendzuck; Marianne Korinth; Corinna Elling-Audersch; Arnd Kleyer; Sebastian Boeltz; Axel J Hueber; Gerhard Krönke; Georg Schett; David Simon
Journal:  Arthritis Res Ther       Date:  2022-05-25       Impact factor: 5.606

Review 3.  The Evolving Role of Microsampling in Therapeutic Drug Monitoring of Monoclonal Antibodies in Inflammatory Diseases.

Authors:  Panagiotis-Dimitrios Mingas; Jurij Zdovc; Iztok Grabnar; Tomaž Vovk
Journal:  Molecules       Date:  2021-03-22       Impact factor: 4.411

4.  Remote self-collection of capillary blood using upper arm devices for autoantibody analysis in patients with immune-mediated inflammatory rheumatic diseases.

Authors:  Joshua Zarbl; Ekaterina Eimer; Camilla Gigg; Gerlinde Bendzuck; Marianne Korinth; Corinna Elling-Audersch; Arnd Kleyer; David Simon; Sebastian Boeltz; Martin Krusche; Johanna Mucke; Felix Muehlensiepen; Nicolas Vuillerme; Gerhard Krönke; Georg Schett; Johannes Knitza
Journal:  RMD Open       Date:  2022-09

5.  Clinical Formulation Bridging of Gefapixant, a P2X3-Receptor Antagonist, for the Treatment of Chronic Cough.

Authors:  Pranav Gupta; Azher Hussain; Anthony P Ford; Steven Smith; Jesse C Nussbaum; Aubrey Stoch; Marian Iwamoto
Journal:  Clin Pharmacol Drug Dev       Date:  2022-05-05

6.  How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis.

Authors:  Melanie Anderson
Journal:  Bioanalysis       Date:  2021-07-19       Impact factor: 2.681

7.  Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.

Authors:  Enaksha R Wickremsinhe; Qin C Ji; Carol R Gleason; Melanie Anderson; Brian P Booth
Journal:  AAPS J       Date:  2020-10-23       Impact factor: 4.009

8.  Optimizing detection of erythropoietin receptor agonists from dried blood spots for anti-doping application.

Authors:  Carmel E Heiland; Magnus Ericsson; Anton Pohanka; Lena Ekström; Alexandre Marchand
Journal:  Drug Test Anal       Date:  2022-03-30       Impact factor: 3.234

  8 in total

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